The Formedix Clinic

Drop in and catch up on the latest news and standards knowledge. No appointment necessary.

How to Describe Multiple Origins for a Value in Define-XML 2

26 April 2018
by Kevin Burges About The Author

There are many common questions people have when creating Define-XML metadata for their datasets. One of these revolves around how to handle data that can come from multiple sources, such as a CRF or eDT. In the simple case you just create a Value List, and specify the Origin on each Value instead of on the Variable.

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Using ODM and CDASH for CRF Design

15 January 2018
by Kevin Burges About The Author

Over the last few years our industry has become familiar with CDISC standards. This has largely been driven by regulation, with national regulators such as FDA and PMDA mandating the use of submission standards such as SDTM, SEND and ADaM.

This post shines a spotlight on the lesser known Operational Data Model (ODM) standard, which is often overlooked as it's not required by any regulators. Why should you be interested in it? Because it can be used as a standard way to define forms, independent of the data collection system. These forms can then be turned into organizational standards, driving data quality and consistency. Finally they can be used to drive your data collection system. In short, they put you in control.

With the right tools in place sponsors and CROs can define data collection standards while remaining flexible in their EDC choice. They can also take control of their EDC build to save time and money. Standardizing your data collection means greatly reduced future study build cost due to re-use and increased consistency between studies. 

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Controlled Terminology and CDASH

15 October 2015
by Fiona Hartley About The Author

Because the focus of CDASH (Clinical Data Acquisition Standards Harmonization) is on data collection, not data reporting, it works a little differently from the rest of the CDISC content standards. Since there is a disconnect between collection and reporting, the point of CDASH is to bridge that gap by showing how data should be collected, minimizing the disparity with reporting.

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Eh... What's SUPPQUAL? An Introduction to Supplemental Qualifiers

8 October 2015
by Fiona Hartley About The Author

In last week’s blog, we looked at the SDTM mapping process and ended on the cliffhanger of the supplemental qualifier. These tricky little tidbits are variables in non-CDISC datasets that cannot be mapped to a variable that matches the SDTM standard. Let’s look at them in a little more detail.

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Annotation Frustration: The pitfalls of non-CDISC CRFs

1 October 2014
by Fiona Hartley About The Author

Any data managers who have attempted to annotate a non-CDASH CRF with SDTM variables will know that it is somewhat of an ordeal.

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Fast and Flexible Standards with CDISC

26 May 2014
by Jim Garety About The Author

Case report forms (CRFs) are not exempt from the watchful eye of standards; they collect data from clinical research studies in a structured fashion. Their credibility exists primarily because they are regulated by peer reviewed standards.

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What can be achieved with CDISC ODM? Standardized libraries of content are just the beginning...

5 March 2014
by Ed Chappell About The Author

Recently, there have been comments about the Lilly ODM library no longer being available on the CodePlex website.

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How to Plan for Controlled Terminology

15 October 2013
by Ed Chappell About The Author

Last week, Mark blogged about the increasing wave of external standards coming our way from NCI, CDISC, TransCelerate and more. So, with these new standards, there obviously comes a need to harmonize data processes and map these to CDISC SDTM in a consistent way. Companies are wondering about the best ways to achieve this consistency and standards management for Controlled Terminology, in particular.

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